Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension. The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE). Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.

Inclusion Criteria: * Age ≥ 18 years * Age ≤ 75 years * HECSI ≥ 18 (moderate to severe hand eczema) * IGA-CHE ≥ 3 * Body mass index (BMI) ≥ 20 kg/m2 * Negative pregnancy test (only women of child-bearing potential (see section 2.8)) * Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potential * Speaks, understands, and reads danish. Exclusion Criteria: * Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis * Diagnosis of current tuberculosis * Current viral hepatitis * History of heart failure (NYHA III-IV) * History of moderate or severe liver failure (Child-Pugh B-C) * Current or former depression with suicidal ideation * Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization * Topical therapy (anti-inflammatory) for chronic hand eczema during study * Systemic therapy for chronic hand eczema 28 days before randomization * Systemic therapy for chronic hand eczema during study * Current treatment with oral dicloxacillin or macrolide * Current treatment with topical antibiotics * Diagnosis of contact eczema of clinical significance 3 months before randomization * Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®) * Confirmed pregnancy * Breast feeding * Blood donation during study * Allergy to roflumilast or any other PDE-4 inhibitor